American Pharmacy News Reports Stories

JAK disrupt a signalling pathway that is believed to play a role in RA-associated inflammation.

Chinese authorities recently approved Pfizer China’s oral Janus kinase inhibitor XELJANZ, with active ingredient tofacitinib citrate, indicated for treating adults with moderate to severely active rheumatoid arthritis. Read More »

Data shared from Phase 3 study on DUPIXENT treatment of atopic dermatitis

Patients who received DUPIXENT in combination with TCS had significantly higher baseline improvements.

Regeneron Pharmaceutical Inc. and Sanofi recently presented the results of their one-year Phase 3 CHRONOS study, showing that investigational drug DUPIXENT combined with topical corticosteroids achieved better results in treating uncontrolled moderate-to-severe atopic dermatitis than TCS alone. Read More »

Mylan launches Exemestane tablets in U.S. market following FDA approval

Exemestane tablets garnered approximately $100 million in sales between February 2016 and the end of January 2017.

The U.S. Food and Drug Administration recently issued its final approval for Mylan’s Abbreviated New Drug Application for its Exemestane Tablets in a 25mg dosage, which are a generic version of Pfizer’s Aromasin tablets. Read More »

FDA committees find OPANA ER's risks outweigh benefits

The FDA will take the committee’s votes into consideration as it determines whether or not to take regulatory action on the drug.

Two U.S. Food and Drug Administration committees recently voted 18 to 8, with one abstention, that Endo International’s OPANA ER (oxymorphone hydrochloride extended release) no longer has a positive risk-to- benefits ratio. Read More »

FDA gives Servier's UCART19 therapy IND clearance

Servier is sponsoring a UCART19 study titled CALM Phase 1 that began in the U.K. in August 2016.

The U.S. Food and Drug Administration recently issued Investigational New Drug clearance for Servier’s UCART19, allowing the company to proceed with clinical development of the allogeneic, gene-edited cellular therapy. Read More »

Mylan gains FDA approval for generic Pristiq in extended-release form

Sales of the tablets in both dosages in the U.S. drew approximately $853 million for the 12-month period ending on Jan. 31.

Mylan N.V. recently launched its Desvenlafaxine extended-release tablets, a generic version of Pfizer’s Pristiq tablets, to treat major depressive disorder in the U.S. market in 50 and 100 mg doses. Read More »

JAMA Cardiology publishes findings from Amgen's 4-year study of Repatha

The OSLER-1 open-label extension study involved 1,324 patients.

The results from Amgen’s four-year follow up OSLER-1 study on Repatha, which is so far the longest PCSK9 inhibitor clinical trial, were recently published in JAMA Cardiology. Read More »

Acorda’s AMPYRA patents upheld by federal officials

Acorda is awaiting the results of a challenge to these patents.

The U.S. Patent and Trademark Office Patent Trials and Appeal Board recently upheld four patents held by Acorda Therapeutics Inc. related to its AMPYRA (dalfampridine) Extended Release Tablets in 10 mg dosages. Read More »

ASHP releases reference manual for pharmacy preceptors

The publication was created by Mate Soric, Stacey Schneider and Scott Wisneski.

The American Society of Health-System Pharmacists recently released “The Effective Pharmacy Preceptor,” a reference to assist pharmacists in training students and residents through experiential education techniques. Read More »

FDA accepts Allergan filing for schizophrenia maintenance treatment drug

The multinational study was randomized, double blind and placebo-controlled and featured parallel groups.

The U.S. Food and Drug Administration has accepted Allergan PLC's filing of a supplemental New Drug Application based on new clinical data that would allow the company to list maintenance on its product label for VRAYLAR (cariprazine), a drug used to treat adults with schizophrenia. Read More »

Maine lawmakers weigh ban on renumeration fees on pharmacies

Maine’s House and Senate are assessing companion bills to prohibit payers from assessing retroactive DIR fees on pharmacies.

Pharmacists in Maine are seeking an end to direct and indirect remuneration fees. Read More »

Alabama legislators discuss collaborative drug therapy management

Mark Iandolo | Mar 15, 2017

Many Alabama pharmacists work with physicians to provide services related to CDTM.

The American Society of Health-System Pharmacists (ASHP) recently announced that the current Alabama legislature session is seeking to attempt to have the state codify collaborative drug therapy management (CDMT) as part of pharmacy practice. Read More »

Pfizer gives additional $530,000 for UICC breast cancer research

Pfizer launched the challenge with UICC in 2015 with $760,000 in funding.

Pfizer Inc. is renewing its partnership with the Union for International Cancer Control through a grant of $530,000 for the Seeding Progress and Resources for the Cancer Community: Metastatic Breast Cancer Challenge. Read More »

Court upholds Pernix's Zohydro ER patent

American Pharmacy News Reports | Mar 14, 2017

Pernix has disputed a generic version of Zohydro ER generated by Actavis Laboratories.

Pernix Therapeutics Holdings Inc. recently announced that it has been given positive feedback on its litigation in regards to the proposed generic version of Zohydro ER with Actavis Laboratories FL Inc. Read More »

Biosimilars Council appeals to Supreme Court for lower drug prices

American Pharmacy News Reports | Mar 11, 2017

The Association for Accessible Medicines has appealed the ruling to the Supreme Court.

The Biosimilars Council is hoping the Supreme Court will acknowledge the savings that biosimilar medications can offer to both patients and health systems. Read More »

Ampion closer to approval to treat severe osteoarthritis of the knee

The study is to be completed prior to the submission of a Biologicals Licensing Application.

The Office of Tissue Advancement Therapies, a branch of the Center for Biologics Evaluation and Research of the FDA, has progressed toward the acceptance of Ampio Pharmaceuticals' Ampion for a viable treatment option for severe osteoarthritis of the knee. Read More »

Bristol-Myers and Pfizer to present on diverse topics at ACC

The companies will present real-world data analyses that showcase their commitment to understanding direct oral anticoagulants in clinical practice.

Bristol-Myers Squibb Co. and Pfizer Inc. will present eight of their abstracts at the American College of Cardiology's 66th Annual Scientific Session in Washington, D.C. March 17-19. Read More »

FDA to review type 2 diabetes drugs from Merck and Pfizer

The NDAs are for medicines containing ertugliflozin, an investigational SGLT2 inhibitor.

Merck, which is known as MSD outside the United States and Canada, and Pfizer Inc. recently announced the acceptance for review of three New Drug Applications by the U.S. Food and Drug Administration. Read More »

Amgen to release results of Repatha cardiovascular outcomes trial